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Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
This study has been completed.
Study NCT00030472   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

February 14, 2002
July 23, 2008
December 2001
 
 
Complete list of historical versions of study NCT00030472 on ClinicalTrials.gov Archive Site
 
 
 
Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.

OBJECTIVES:

  • Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.

Phase II
Interventional
Treatment
Cervical Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
 
Rose PG, Blessing JA, Lele S, Abulafia O. Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Aug;102(2):210-3. Epub 2006 Feb 14.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma (SCC) of the cervix

    • Persistent or recurrent progressive disease
  • Must have failed local therapeutic measures and considered incurable
  • 1 prior chemotherapeutic regimen for SCC of the cervix required

    • Initial treatment may include high-dose therapy, consolidation, or extended therapy
  • Ineligible for a higher priority GOG protocol
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • Target lesion may not be within a previously irradiated field

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least 100,000/mm3
  • Absolute neutrophil count at least 1,500/mm3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No congestive heart failure
  • No unstable angina
  • No myocardial infarction or new cardiac arrhythmia in the past 6 months

Other:

  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 1 prior noncytotoxic biologic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic cytostatic regimen for recurrent or persistent disease management)
  • At least 3 weeks since prior biologic or immunologic therapy for SCC of the cervix

Chemotherapy:

  • See Disease Characteristics
  • No prior doxorubicin or doxorubicin HCl liposome
  • 1 prior noncytotoxic cytostatic regimen allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic biologic regimen for recurrent or persistent disease management)
  • No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
  • Recovered from prior chemotherapy

Endocrine therapy:

  • At least 1 week since prior hormonal therapy for SCC of the cervix
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery:

  • Recovered from prior surgery

Other:

  • At least 3 weeks since other prior therapy for SCC of the cervix
  • No prior anticancer treatment that precludes study
Female
 
No
 
United States,   Norway
 
 
NCT00030472
 
GOG-0127R
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter G. Rose, MD MetroHealth Cancer Care Center at MetroHealth Medical Center
National Cancer Institute (NCI)
September 2004

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.